Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs
This guidance document applies to all biologic drug submissions where the sponsor seeks authorization for sale based on demonstrated similarity to a previously approved biologic drug and relies, in part, on prior information regarding that biologic drug in order to present a reduced clinical and non-clinical package as part of the submission.
- Publisher - Current Organization Name: Health Canada
- Licence: Open Government Licence - Canada
Data and Resources
-
Guidance Document: Information and Submission Requirements for Biosimilar Biologic DrugsHTMLEnglish publication HTML
-
Guidance Document: Information and Submission Requirements for Biosimilar Biologic DrugsHTMLFrench publication HTML
Similar records